ID

31973

Descripción

Iyengar Yoga for Young People With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01096823

Link

https://clinicaltrials.gov/show/NCT01096823

Palabras clave

Versiones (1)
  1. 9/10/18 9/10/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

9 de octubre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT01096823

Inglés

Eligibility Rheumatoid Arthritis NCT01096823

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
people with rheumatoid arthritis between the ages of 16-35
Descripción

Rheumatoid Arthritis | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0001779
diagnosis of ra, according to the revised 1987 acr criteria, or juvenile idiopathic arthritis (jia) for at least 6 months
Descripción

Rheumatoid Arthritis Duration | Juvenile idiopathic arthritis Duration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C3495559
UMLS CUI [2,2]
C0449238
concomitant use of disease modifying antirheumatic medications (hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, etc) biologic agents (infliximab, etanercept, adalimumab, abatacept, rituximab, anakinra) is permitted provided that the dose(s) have been stable for 4 weeks prior to screening, and may reasonably be expected to remain on stable doses throughout the duration of the trial
Descripción

Disease-Modifying Antirheumatic Drugs Dose Stable | Hydroxychloroquine | Sulfasalazine | Methotrexate | leflunomide | Biological agents Dose Stable | infliximab | Etanercept | adalimumab | abatacept | rituximab | anakinra

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2]
C0020336
UMLS CUI [3]
C0036078
UMLS CUI [4]
C0025677
UMLS CUI [5]
C0063041
UMLS CUI [6,1]
C0005515
UMLS CUI [6,2]
C0178602
UMLS CUI [6,3]
C0205360
UMLS CUI [7]
C0666743
UMLS CUI [8]
C0717758
UMLS CUI [9]
C1122087
UMLS CUI [10]
C1619966
UMLS CUI [11]
C0393022
UMLS CUI [12]
C0245109
concomitant use of non-steroidal anti-inflammatory drugs (nsaids) and low dose corticosteroids (e.g prednisone at doses of 10 /day prednisone or equivalent is permitted provided that the dose(s) have been stable for 4 weeks prior to screening, and may reasonably be expected to remain on stable doses throughout the duration of the trial
Descripción

Anti-Inflammatory Agents, Non-Steroidal | Adrenal Cortex Hormones Low dose | Prednisone Dose Stable U/day | Prednisone Dose Stable Equivalent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003211
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0445550
UMLS CUI [3,1]
C0032952
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [3,4]
C0456683
UMLS CUI [4,1]
C0032952
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
UMLS CUI [4,4]
C0205163
disease activity, as defined using a 28 joint count by > 5 tender joints, > 5 swollen joints, and one of the following: esr > 28 mm/hour, crp > 1.5 mg/dl, duration of a.m. stiffness > 45 minutes
Descripción

Disease activity | Tender 28 joint count | Swollen 28 joint count | Erythrocyte sedimentation rate measurement | C-reactive protein measurement | Morning stiffness Duration

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3871171
UMLS CUI [2]
C2711398
UMLS CUI [3]
C2711873
UMLS CUI [4]
C1176468
UMLS CUI [5]
C0201657
UMLS CUI [6,1]
C0457086
UMLS CUI [6,2]
C0449238
ability to provide written informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
ability to speak and understand english
Descripción

Able to speak English Language | Comprehension English Language

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0233733
UMLS CUI [2,2]
C0376245
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
intra-articular steroid injections within 4 weeks of screening
Descripción

Intraarticular steroid injection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2064783
treatment with any investigational agent within 8 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
history of drug, alcohol, or chemical abuse within 6 months prior to screening
Descripción

Substance Use Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion that might affect the interpretation of the results or render the patient at high risk from treatment complications
Descripción

Other disease Affecting Interpretation of results | Dysfunction metabolic Affecting Interpretation of results | Physical Examination Affecting Interpretation of results | Laboratory test finding Affecting Interpretation of results | Other disease Study Subject Participation Status At risk Complications of treatment | Dysfunction metabolic Study Subject Participation Status At risk Complications of treatment | Physical Examination Study Subject Participation Status At risk Complications of treatment | Laboratory test finding Study Subject Participation Status At risk Complications of treatment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C3526596
UMLS CUI [2,1]
C3887504
UMLS CUI [2,2]
C0311400
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C3526596
UMLS CUI [3,1]
C0031809
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C3526596
UMLS CUI [4,1]
C0587081
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C3526596
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C2348568
UMLS CUI [5,3]
C1444641
UMLS CUI [5,4]
C0679861
UMLS CUI [6,1]
C3887504
UMLS CUI [6,2]
C0311400
UMLS CUI [6,3]
C2348568
UMLS CUI [6,4]
C1444641
UMLS CUI [6,5]
C0679861
UMLS CUI [7,1]
C0031809
UMLS CUI [7,2]
C2348568
UMLS CUI [7,3]
C1444641
UMLS CUI [7,4]
C0679861
UMLS CUI [8,1]
C0587081
UMLS CUI [8,2]
C2348568
UMLS CUI [8,3]
C1444641
UMLS CUI [8,4]
C0679861
inability to comply with study and follow-up procedures
Descripción

Protocol Compliance Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
currently pregnant
Descripción

Pregnancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
inability to speak or understand english
Descripción

Lacking Able to speak English Language | Comprehension English Language Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0564215
UMLS CUI [1,3]
C0376245
UMLS CUI [2,1]
C0233733
UMLS CUI [2,2]
C0376245
UMLS CUI [2,3]
C1299582
any recent injury.
Descripción

Recent injury

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0332665
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Similar models

Eligibility Rheumatoid Arthritis NCT01096823

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis | Age
Item
people with rheumatoid arthritis between the ages of 16-35
boolean
C0003873 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Rheumatoid Arthritis Duration | Juvenile idiopathic arthritis Duration
Item
diagnosis of ra, according to the revised 1987 acr criteria, or juvenile idiopathic arthritis (jia) for at least 6 months
boolean
C0003873 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C3495559 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Disease-Modifying Antirheumatic Drugs Dose Stable | Hydroxychloroquine | Sulfasalazine | Methotrexate | leflunomide | Biological agents Dose Stable | infliximab | Etanercept | adalimumab | abatacept | rituximab | anakinra
Item
concomitant use of disease modifying antirheumatic medications (hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, etc) biologic agents (infliximab, etanercept, adalimumab, abatacept, rituximab, anakinra) is permitted provided that the dose(s) have been stable for 4 weeks prior to screening, and may reasonably be expected to remain on stable doses throughout the duration of the trial
boolean
C0242708 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0020336 (UMLS CUI [2])
C0036078 (UMLS CUI [3])
C0025677 (UMLS CUI [4])
C0063041 (UMLS CUI [5])
C0005515 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0205360 (UMLS CUI [6,3])
C0666743 (UMLS CUI [7])
C0717758 (UMLS CUI [8])
C1122087 (UMLS CUI [9])
C1619966 (UMLS CUI [10])
C0393022 (UMLS CUI [11])
C0245109 (UMLS CUI [12])
Anti-Inflammatory Agents, Non-Steroidal | Adrenal Cortex Hormones Low dose | Prednisone Dose Stable U/day | Prednisone Dose Stable Equivalent
Item
concomitant use of non-steroidal anti-inflammatory drugs (nsaids) and low dose corticosteroids (e.g prednisone at doses of 10 /day prednisone or equivalent is permitted provided that the dose(s) have been stable for 4 weeks prior to screening, and may reasonably be expected to remain on stable doses throughout the duration of the trial
boolean
C0003211 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C0445550 (UMLS CUI [2,2])
C0032952 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0456683 (UMLS CUI [3,4])
C0032952 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C0205163 (UMLS CUI [4,4])
Disease activity | Tender 28 joint count | Swollen 28 joint count | Erythrocyte sedimentation rate measurement | C-reactive protein measurement | Morning stiffness Duration
Item
disease activity, as defined using a 28 joint count by > 5 tender joints, > 5 swollen joints, and one of the following: esr > 28 mm/hour, crp > 1.5 mg/dl, duration of a.m. stiffness > 45 minutes
boolean
C3871171 (UMLS CUI [1])
C2711398 (UMLS CUI [2])
C2711873 (UMLS CUI [3])
C1176468 (UMLS CUI [4])
C0201657 (UMLS CUI [5])
C0457086 (UMLS CUI [6,1])
C0449238 (UMLS CUI [6,2])
Informed Consent
Item
ability to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Able to speak English Language | Comprehension English Language
Item
ability to speak and understand english
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0233733 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Intraarticular steroid injection
Item
intra-articular steroid injections within 4 weeks of screening
boolean
C2064783 (UMLS CUI [1])
Investigational New Drugs
Item
treatment with any investigational agent within 8 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
boolean
C0013230 (UMLS CUI [1])
Substance Use Disorders
Item
history of drug, alcohol, or chemical abuse within 6 months prior to screening
boolean
C0038586 (UMLS CUI [1])
Other disease Affecting Interpretation of results | Dysfunction metabolic Affecting Interpretation of results | Physical Examination Affecting Interpretation of results | Laboratory test finding Affecting Interpretation of results | Other disease Study Subject Participation Status At risk Complications of treatment | Dysfunction metabolic Study Subject Participation Status At risk Complications of treatment | Physical Examination Study Subject Participation Status At risk Complications of treatment | Laboratory test finding Study Subject Participation Status At risk Complications of treatment
Item
any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion that might affect the interpretation of the results or render the patient at high risk from treatment complications
boolean
C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C3526596 (UMLS CUI [1,3])
C3887504 (UMLS CUI [2,1])
C0311400 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C3526596 (UMLS CUI [2,4])
C0031809 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C3526596 (UMLS CUI [3,3])
C0587081 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C3526596 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C2348568 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C0679861 (UMLS CUI [5,4])
C3887504 (UMLS CUI [6,1])
C0311400 (UMLS CUI [6,2])
C2348568 (UMLS CUI [6,3])
C1444641 (UMLS CUI [6,4])
C0679861 (UMLS CUI [6,5])
C0031809 (UMLS CUI [7,1])
C2348568 (UMLS CUI [7,2])
C1444641 (UMLS CUI [7,3])
C0679861 (UMLS CUI [7,4])
C0587081 (UMLS CUI [8,1])
C2348568 (UMLS CUI [8,2])
C1444641 (UMLS CUI [8,3])
C0679861 (UMLS CUI [8,4])
Protocol Compliance Unable
Item
inability to comply with study and follow-up procedures
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Pregnancy
Item
currently pregnant
boolean
C0032961 (UMLS CUI [1])
Lacking Able to speak English Language | Comprehension English Language Unable
Item
inability to speak or understand english
boolean
C0332268 (UMLS CUI [1,1])
C0564215 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
C0233733 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Recent injury
Item
any recent injury.
boolean
C0332665 (UMLS CUI [1])
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